Articles: outcome-assessment-health-care.
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Randomized Controlled Trial Multicenter Study
Glyburide Advantage in Malignant Edema and Stroke (GAMES-RP) Trial: Rationale and Design.
Patients with large territory infarction are at high risk of cerebral edema and neurological deterioration, including death. Preclinical studies have shown that a continuous infusion of glyburide blocks edema formation and improves outcome. We hypothesize that treatment with RP-1127 (Glyburide for Injection) reduces formation of brain edema in patients after large anterior circulation infarction. ⋯ GAMES-RP was designed to provide critical information regarding glyburide for injection in patients with large hemispheric stroke and will inform the design of future studies.
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J Intensive Care Med · Feb 2016
Multicenter StudyDaytime Versus Nighttime Extubations: A Comparison of Reintubation, Length of Stay, and Mortality.
Despite studies regarding outcomes of day versus night medical care, consequences of nighttime extubations are unknown. It may be favorable to extubate patients off-hours, as soon as weaning parameters are met, since this could decrease complications and shorten length of stay (LOS). Conversely, nighttime extubation could be deleterious, as staffing varies during this time. We hypothesized that patients have similar reintubation rates, irrespective of extubation time. ⋯ Intensive care unit extubations at night did not have higher likelihood of reintubation, LOS, or mortality compared to those during the day. Since patients should be extubated as soon as they meet parameters in order to potentially decrease complications of mechanical ventilation, these data provide no support for delaying extubation until daytime.
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Randomized Controlled Trial Multicenter Study
Opicapone as an adjunct to levodopa in patients with Parkinson's disease and end-of-dose motor fluctuations: a randomised, double-blind, controlled trial.
Opicapone is a novel, once-daily, potent third-generation catechol-O-methyltransferase inhibitor. We aimed to assess the safety and efficacy of opicapone as an adjunct to levodopa compared with placebo or entacapone in patients with Parkinson's disease and motor fluctuations. ⋯ BIAL.
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Journal of neurotrauma · Feb 2016
Multicenter Study Observational StudyResponsiveness, Sensitivity and Minimally Detectable Difference of the Graded and Redefined Assessment of Strength, Sensibility, and Prehension, Version 1.0 (GRASSP V1).
As spinal cord injury (SCI) trials begin to involve subjects with acute cervical SCI, establishing the property of an upper limb outcome measure to detect change over time is critical for its usefulness in clinical trials. The objectives of this study were to define responsiveness, sensitivity, and minimally detectable difference (MDD) of the Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP). An observational, longitudinal study was conducted. ⋯ GRASSP demonstrates good responsiveness and excellent sensitivity that is superior to ISNCSCI and SCIM III. MDD values are useful in the evaluation of interventions in both clinical and research settings. The responsiveness and sensitivity of GRASSP make it a valuable condition-specific measure in tetraplegia, where changes in upper limb neurological and functional outcomes are essential for evaluating the efficacy of interventions.
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Randomized Controlled Trial Multicenter Study
Supplemental parenteral nutrition in critically ill patients: a study protocol for a phase II randomised controlled trial.
Nutrition is one of the fundamentals of care provided to critically ill adults. The volume of enteral nutrition received, however, is often much less than prescribed due to multiple functional and process issues. To deliver the prescribed volume and correct the energy deficit associated with enteral nutrition alone, parenteral nutrition can be used in combination (termed "supplemental parenteral nutrition"), but benefits of this method have not been firmly established. A multi-centre, randomised, clinical trial is currently underway to determine if prescribed energy requirements can be provided to critically ill patients by using a supplemental parenteral nutrition strategy in the critically ill. ⋯ This trial aims to determine if provision of a supplemental parenteral nutrition strategy to critically ill adults will increase energy intake compared to usual care in Australia and New Zealand. Trial outcomes will guide development of a subsequent larger randomised controlled trial.